BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NP 53 - BP

    MDR report key: 2883822 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02887
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K875199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLD AND POOR SENSING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NP 53 - BP PACER LEAD DTB BIOTRONIK SE & CO. KG 108994

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization